BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 24071390 · Received January 14, 2026

    Report

    Report Number
    2183553-2026-00001
    Event Type
    Injury
    Date Received
    January 14, 2026
    Date of Event
    December 21, 2025
    Report Date
    February 17, 2026
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K160621
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B4; G1, 3, 6; H2, 3, 6 H3: GE HEALTHCARE HAS COMPLETED ITS INVESTIGATION. A NURSING TECHNICIAN ENTERED THE MR SCAN ROOM WITH A FERROMAGNETIC STEP LADDER TO ASSIST A PATIENT FROM THE MR TABLE. THE FERROUS OBJECT BECAME ATTRACTED TO THE MAGNETIC FIELD AND CONTACTED THE PATIENT¿S FOOT RESULTING IN INJURY TO THEIR TOE. THE SITE CONFIRMED THAT MR SAFETY SIGNAGE WAS APPROPRIATELY DISPLAYED, THE STEP LADDER WAS LABELED AS NOT MR SAFE, AND THAT THE INVOLVED NURSING TECHNICIAN HAD RECEIVED TRAINING IN MR SAFETY PROTOCOLS. THE ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE BE USE ERROR (INATTENTIVE PERSONNEL). THE OPERATOR DOCUMENTATION OUTLINES THE RISKS AND SAFETY PRECAUTIONS ASSOCIATED WITH BRINGING FERROUS MATERIALS INTO THE SCAN ROOM WHILE THE MAGNET IS AT FIELD. THE RISK ANALYSIS DETERMINED THAT NO ADDITIONAL MITIGATIONS ARE AVAILABLE TO REDUCE THE RISK, AND THE RISK HAS BEEN REDUCED AS FAR AS POSSIBLE. NO FURTHER ACTIONS ARE PLANNED BY GE HEALTHCARE.

    Additional Manufacturer Narrative · 0

    LEGAL MANUFACTURER: HCS MR - 3200 N GRANDVIEW BLVD. USA WAUKESHA, WI 53188. D: THERE ARE NO ADDITIONAL DEVICE IDENTIFICATION NUMBERS. H3, 6: GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NURSING TECHNICIAN ENTERED THE MR SCAN ROOM WITH A FERROMAGNETIC STEP LADDER TO ASSIST A PATIENT FROM THE MR TABLE. THE STEP LADDER BECAME ATTRACTED AND ATTACHED TO THE MAGNET, CONTACTING THE PATIENT'S RIGHT FOOT. THE PATIENT SUSTAINED A FRACTURE OF THE RIGHT FIFTH TOE, WHICH WAS TREATED WITH IMMOBILIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134512 NA NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE MEDICAL SYSTEMS, LLC SIGNA PIONEER

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Other